At a glance
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A Randomized Trial of Extracorporeal Photopheresis, Pentostatin, and Total Body Irradiation Versus Pentostatin and Total Body Irradiation in Patients Undergoing Reduced Intensity Allogeneic Stem Cell Transplantation for the Treatment of Malignancies
In Brief
A Phase 2 clinical trial evaluating extracorporeal photopheresis, Pentostatin, and 1 other intervention for Hematologic Malignancies. Completed, enrolled 14 participants across 3 sites.
Detailed Summary
This is a study to explore the use of a reduced intensity transplant conditioning regimen. A conditioning regimen is the treatment that is given to prepare a body for the new bone marrow that will be received from a donor. Reduced intensity conditioning uses lower doses of chemotherapy than conventional conditioning regimens. The use of lower doses of drugs and radiation cause fewer side effects. Reduced intensity regimens have been offered to older patients or patients at increased risk for transplant-related side effects and have been shown to be safe and effective. Reduced intensity conditioning regimens are now considered for many patients who are undergoing transplant.
Study Details
Timeline
Interventions
Extracorporeal photopheresis (ECP) is the ex vivo exposure of the leukocyte rich fraction to ultraviolet light in the presence of 8-methoxypsoralen.
pentostatin 8mg/m2 over 48 hours by continuous infusion
600cGy TBI in 3 200cGy TBI fractions
pentostatin 8mg/m2 over 48 hours by continuous infusion
600cGy TBI in 3 200cGy TBI fractions